AB0446 SAFETY OF BIOLOGICAL THERAPIES: DATA FROM THE BIOBADAGUAY REGISTRY
Authors: P. DE Abreu Trigueros, S. Cabrera-Villalba, P. Melgarejo, Z. Morel, L. Roman, A. Ramagli, A. Amarilla, C. Brunengo Cairus, G. Bartesaghi Moreno, E. Leiva, M. Zarza, R. Rolón, P. Pusineri, C. Parodi, V. Valinotti, C. Vega, M. Zanotti, S. Consani-Fernández, G. Avila
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> BIOBADAGUAY is the Paraguayan/Uruguayan registry of adverse events (AE) in patients with inflammatory rheumatic conditions under biologic therapy (BT). <h3>Objectives</h3> Determine the frequency and severity of AE of patients under BT in the BIOBADAGUAY registry. <h3>Methods</h3> Prospective, observational study of undetermined length to verify the efficacy, safety, and survival of the BT. The methodology applied is available at https://biobadaguay.ser.es. For the present study epidemiological and clinical variables, BT, type, and severity of AE were analyzed. The incidence rate (IR) was calculated as the total number of adverse events per 1000 patients/year and the incidence rate ratio (IRR) was analyzed using the Poisson regression model. (Significance value 0,05) <h3>Results</h3> 1104 patients with TB were analyzed, between 2016 and 2022. 73.28% were women, mean age at treatment initiation was 42±17.1 years. The most frequent diagnosis was rheumatoid arthritis (RA): 686 patients (62.4%). There were 1375 treatment cycles. 1365 AE were observed, 1191 (87.2%) were non-severe, 161 (11.8%) severe and 13 (0.95%) mortal. The IR of AE was 251.75 (238.6-265.8), for severe AE 32.1 (27.5-37.2). Infection was the most frequent AE in 731/1365 (55% of total AA): non-severe 661 (88%), 86 (11.5%) severe and 4 (0.5%) mortal. The IR of infections was 138.4 (126.69-265.47), 32.1 (27.48-37.2%) for severe infections. When analyzing the IR of AE according to diagnosis, it was observed that RA is associated with a higher IR of global AE when compared to other diagnoses (IRR=1.35 [95% CI,1.1-1.7] p=0.0088), and severe AE (IRR=1.72 [95% CI,1.2-2.5] p=0.006). Psoriatic arthritis (PsA) and ankylosing spondylitis (AS) were associated with lower overall IR of global AE: IRR=0.57 [95% CI,0.4-0.9] (p=0.007) and IRR=0.66 [95% CI,0.5-1] (p=0.04), respectively. corticosteroid use was associated with a higher global AE IR (IRR=1.46 [95% CI,1.2-1.8] p=0.0009). When IR was analyzed according to severity, it was observed that the second and subsequent cycles of BT were significantly associated with a higher IR of global and non-severe AE compared to the first cycle of BT (Table 1). Treatment with anti-TNF was significantly associated with lower IR of global and mortal AE compared to non-anti-TNF (Table 1). <h3>Conclusion</h3> AE were in general non-severe, and infections were the most frequent. RA and concomitant treatment corticosteroid presented a higher IRR of global AE, whereas PsA and AS a lower IRR of AE. Second and Subsequent cycles of BT presented a higher IRR of global an AE. The RA diagnosis presented a higher rate of severe AE. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> PALOMA DE ABREU TRIGUEROS Grant/research support from: Casa Boller -Roche, Sonia Cabrera-Villalba Grant/research support from: Casa Boller Roche, Patricia Melgarejo Grant/research support from: Casa Boller Roche, ZOILO MOREL Grant/research support from: Casa Boller- Roche, Lourdes Roman Grant/research support from: Casa Boller -Roche, ALICIA RAMAGLI: None declared, Angelica Amarilla Grant/research support from: Casa Boller -Roche, Cristina Brunengo Cairus: None declared, Gonzalo Bartesaghi Moreno: None declared, Evelyn Leiva Grant/research support from: Casa Boller -Roche, Mariela Zarza Grant/research support from: Casa Boller -Roche, Roger Rolón Grant/research support from: Casa Boller -Roche, Paola Pusineri Grant/research support from: Casa Boller -Roche, Clyde PArodi Grant/research support from: Casa Boller -Roche, Vannia Valinotti Grant/research support from: Casa Boller -Roche, CYNTHIA VEGA Grant/research support from: Casa Boller -Roche, Magali Zanotti Grant/research support from: Casa Boller -Roche, Sandra Consani-Fernández: None declared, Gabriela Avila Grant/research support from: Casa Boller -Roche.